tetano
Editor, Senior Moderator
Euro Surveill. 2017 May 4;22(18). pii: 30527. doi: 10.2807/1560-7917.ES.2017.22.18.30527.
[h=1]Passive enhanced safety surveillance for Vaxigrip and Intanza 15 ?g in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16.[/h] Bricout H[SUP]1[/SUP], Chabanon AL[SUP]1[/SUP], Souverain A[SUP]1[/SUP], Sadorge C[SUP]1[/SUP], Vesikari T[SUP]2[/SUP], Caroe TD[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 ?g to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 ?g vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities' requirements; further fine tuning of the methodology is under discussion between all stakeholders.
This article is copyright of The Authors, 2017.
[h=4]KEYWORDS:[/h] Influenza; Influenza virus; Surveillance; immunisation; routine pharmacovigilance; vaccine; vaccine safety
PMID: 28494843 DOI: 10.2807/1560-7917.ES.2017.22.18.30527
[h=1]Passive enhanced safety surveillance for Vaxigrip and Intanza 15 ?g in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16.[/h] Bricout H[SUP]1[/SUP], Chabanon AL[SUP]1[/SUP], Souverain A[SUP]1[/SUP], Sadorge C[SUP]1[/SUP], Vesikari T[SUP]2[/SUP], Caroe TD[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] Enhanced safety surveillance (ESS) was conducted in the United Kingdom and Finland for Vaxigrip and Intanza 15 ?g to comply with the European Medicines Agency interim guidance aimed to detect any potential increase in reactogenicity in near real time following the annual update of the influenza vaccine strain composition. This pilot passive ESS was established to strengthen safety monitoring by facilitating spontaneous vaccinee reports and estimating near real-time vaccinee exposure. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days post vaccination during the northern hemisphere 2015/16 influenza season. Among the Vaxigrip vaccinees (n = 1,012), 32 (3.2%) reported a total of 122 suspected ARs, including 110 suspected ARs that occurred within 7 days post vaccination. Among the Intanza 15 ?g vaccinees (n = 1,017), 31 (3.0%) reported a total of 114 suspected ARs, including 99 that occurred within 7 days post-vaccination. These results were consistent with the known safety profile of the two vaccines and did not show any change in reactogenicity or safety concerns. This passive ESS showed improved data reporting and demonstrated its suitability to health authorities' requirements; further fine tuning of the methodology is under discussion between all stakeholders.
This article is copyright of The Authors, 2017.
[h=4]KEYWORDS:[/h] Influenza; Influenza virus; Surveillance; immunisation; routine pharmacovigilance; vaccine; vaccine safety
PMID: 28494843 DOI: 10.2807/1560-7917.ES.2017.22.18.30527